PEN-3 Intervention for Maternal Health
(Time4Mom Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on improving maternal health by addressing high rates of maternal mortality and severe complications in the Mississippi Delta, particularly among Black women. The researchers aim to build trust and boost engagement in postpartum healthcare through a strategy involving the community and enhancing health literacy. The treatment being tested is the PEN-3 Intervention Model, which uses a sociocultural approach to strengthen connections between patients and healthcare providers. Eligible participants are women who have had high-risk pregnancies and live in one of five specific counties in the Mississippi Delta. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform maternal healthcare in their community.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that the PEN-3 Intervention Model is safe for maternal health?
Research has shown that the PEN-3 Intervention Model effectively improves health behaviors. For example, one study found it increased breast cancer screening rates. This indicates that the PEN-3 model can be safely applied in various health settings.
The PEN-3 model aids in understanding how culture influences health. Various studies have used it to enhance health practices, particularly among different cultural groups. Reports have not indicated any negative effects from using the PEN-3 model. It is not a drug or medical procedure but a method to improve health behaviors.
Overall, the PEN-3 model has been safely used in past health programs, which is promising for its application in this trial to enhance maternal health.12345Why are researchers excited about this trial?
Researchers are excited about the PEN-3 Intervention Model because it uses a sociocultural approach to enhance maternal health outcomes. Unlike traditional treatments that might focus primarily on medical or physical interventions, this model emphasizes the importance of understanding and improving the connections between patients and clinical providers within their cultural context. By tailoring healthcare strategies to fit the unique cultural backgrounds and social dynamics of patients, this innovative method aims to foster more effective and personalized health support, potentially leading to better maternal health outcomes.
What evidence suggests that the PEN-3 Intervention Model is effective for improving maternal health outcomes?
Research has shown that the PEN-3 Intervention Model, which participants in this trial will experience, improves health habits by considering cultural backgrounds. For example, one study found that using the PEN-3 model increased participation in breast and cervical cancer screenings. This model involves families and communities in creating health programs that respect cultural values. The goal is to build trust and increase healthcare involvement, which is crucial for reducing disparities in maternal health. By involving the community, it improves health outcomes for mothers, especially in areas with significant health disparities like the Mississippi Delta.12567
Who Is on the Research Team?
Mary Shaw, PhD
Principal Investigator
Jackson State University
Henning Temeier, PhD, MD
Principal Investigator
Harvard School of Public Heatlh
Are You a Good Fit for This Trial?
This trial is for women in the Mississippi Delta, especially Black women, who are pregnant or postpartum. It aims to address disparities in maternal health and healthcare outcomes by building trust and engagement with community-focused interventions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Implementation of a community health worker home visiting program and a multilevel communication strategy to increase trust and engagement in postpartum healthcare
Follow-up
Participants are monitored for severe maternal morbidity rates and ED visits up to 1 year postpartum
What Are the Treatments Tested in This Trial?
Interventions
- The PEN-3 Intervention Model
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jackson State University
Lead Sponsor
University of Mississippi Medical Center
Collaborator
Harvard School of Public Health (HSPH)
Collaborator
Mississippi State Department of Health
Collaborator